Unrated Drug recall · FDA · Published August 8, 2022

Akorn Timolol Ophthalmic Solution Recall: Unknown Impurity Risk

Akorn recalls 0.5% Timolol Maleate eye drops due to potential impurities at 12-month stability. Consumers with prescription vials from specific lot numbers should check if affected.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1471-2022Drug Akorn ›

Recall notice

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

Take action

Contact the company

Recalling firmAkorn, Inc5605 Centerpoint Ct Ste B · Gurnee, IL 60031-5278

✎ GovInfoNow plain-language explainer

Akorn is recalling prescription timolol eye drops that may contain an unknown impurity at the 12-month stability point. This could pose a risk to users, though the exact danger isn't specified in the recall notice. Read more at govinfonow.com/recall/34376-akorn-timolol-ophthalmic-solution-recall-unknown-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/34376-akorn-timolol-ophthalmic-solution-recall-unknown-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-1471-2022

Cite this page

“Akorn Timolol Ophthalmic Solution Recall: Unknown Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34376-akorn-timolol-ophthalmic-solution-recall-unknown-impurity-risk. Based on FDA recall #D-1471-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1471-2022%22&limit=1).

The FDA announced on 2022-08-08 that Akorn, Inc. is voluntarily recalling Timolol Maleate Ophthalmic Solution due to failed impurity specifications. The agency classified the Class III recall as ongoing.

How to tell if you have it

Brand: Akorn
Product: Timolol Maleate Ophthalmic Solution, USP, 0.5%
Packaging: 5 x 0.3 mL Single-Dose Vials
NDC: 17478-189-24
Lot #: 9N72
Expiration Date: EXP 09/30/2022

The hazard

The recall addresses the identification of an unknown impurity at the 12-month stability point. The FDA stated that the product failed to meet impurity and degradation specifications.

Context

GovInfoNow's records show Akorn, Inc. has 64 other recalls on record since 2014-08-05. Recent similar recalls include an Akorn Clobetasol Ointment recall for stability issues on 2023-04-26 and an Akorn Atropine Sulfate Ophthalmic Solution recall for a stability issue on 2023-01-30. Other recent recalls of similar products include a Sun Pharmaceutical Fluocinolone Acetonide Solution recall for impurity risk on 2025-12-30, an ImprimisRx Povidone Iodine Ophthalmic Solution recall for subpotent drug risk on 2026-08-24, and an Apotex Brimonidine/Timolol Eye Drops recall for lack of sterility risk on 2026-03-05.

How to tell if you have this one

Check for the lot number 9N72 on the vial label, which expires September 30, 2022. The product is a prescription-only 0.5% Timolol Maleate Ophthalmic Solution in 5 single-dose vials.

Brand
Akorn
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Vial Label
Look for the lot number 9N72 on the vial label, which expires September 30, 2022.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 30 days after the firm started it.

Aug 8, 2022Firm started the recall
Aug 29, 2022FDA classified it Class III
Sep 7, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/34376-akorn-timolol-ophthalmic-solution-recall-unknown-impurity-risk">Akorn Timolol Ophthalmic Solution Recall: Unknown Impurity Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1471-2022 (August 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1471-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.